BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2241415 · Received August 18, 2011

    Report

    Report Number
    1644487-2011-01907
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 20, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A GENERATOR REPLACEMENT DUE TO "NO ACTIVITY" IN HER GENERATOR. THE PATIENT'S GENERATOR WAS EXPLANTED AND REPLACED. THE GENERATOR HAD SINCE BEEN RETURNED TO THE MANUFACTURE; HOWEVER, PRODUCT ANALYSIS IS NOT YET COMPLETE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON'S OFFICE INDICATING THAT THE PATIENT HAD BEEN REFERRED TO THE SURGEON BECAUSE HER GENERATOR WASN'T WORKING, AND SHE NEEDED A REPLACEMENT. SHE ALSO NOTED HAVING AN INCREASE IN SEIZURES. FOLLOW UP WITH A NURSE AT THE PATIENT'S TREATING NEUROLOGIST'S OFFICE INDICATED THAT THE PATIENT WAS SEEN ON (B)(6) 2011 AND AT THAT TIME, THEY COULD NOT COMMUNICATE WITH HER GENERATOR. THE NURSE INDICATED THAT THE PATIENT'S INCREASE IN SEIZURES WAS DUE TO THE GENERATOR NOT WORKING; HOWEVER, SHE COULD NOT CONFIRM THAT THE GENERATOR WAS AT END OF SERVICE. THE NURSE WAS ALSO NOT ABLE TO PROVIDE ANY PROGRAMMING OR DIAGNOSTIC HISTORY FOR THE DEVICE. SHE WAS ALSO NOT SURE IF THE PATIENT'S INCREASE IN SEIZURES WAS ABOVE HER PRE-VNS BASELINE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 7732

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention